Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and   non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad   range of prescriptions and meet the needs of any professional dialysis care setting.

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease.   We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely   versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need   for pre-mixed dialysate bags or external water-treatment systems. 

The Clinical Validation Engineer will play a critical role in ensuring that our products are intuitive, safe, and effective for end-users. This individual will lead user need and clinical validation design activities from concept through production. You will leverage your expertise clinical workflows to   drive the design and validation of complex systems, ensuring compliance with regulatory standards and industry best practices. 

Responsibilities

• Plan and execute clinical use and User Need validation studies to assess product performance in real-world settings.  
• Work closely with clinical partners and stakeholders to design studies that accurately reflect clinical environments and workflows.  
• Plan and conduct clinical validation studies to inform clinical workflows and UX design.          
• Collect and analyze data to validate the safety and effectiveness of products in clinical use.  
• Document findings and provide recommendations for design improvements based on clinical use validation results.  
• Provide clinical workflow and harm assessment as part of the risk management process (SHA, DFMEAs)
• Provide assessments on clinical workflows on prototypes and action design changes.
• Collaborate with regulatory affairs and human factors engineering team to ensure all human factors documentation meets FDA requirements.  
• Responsible for coordinating with functional and cross functional team members to ensure project milestones are achieved.  
• Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team

Required Skills & Abilities

• Proven track record of leading clinical validation and user validation studies in product development cycles.  
• Experience in clinical workflows of hemodialysis systems or related medical device systems 
• Knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.  
• Experience with user interface design and evaluation.  
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.  
• Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.  
• Experience in user need and human factors engineering for medical device systems is a plus (e.g. FDA Human Factors Guidance, IEC 62366, HE75)
• Certified dialysis technician and/or dialysis nurse is a plus 

Education & Experience

• Bachelor’s or master’s degree in Life Sciences, Human Factors Engineering, Bioengineering, Industrial Engineering, or a related field. 
• Minimum of 3-5 years of experience in user clinical validation, preferably in medical devices. 

Travel

• Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attend attendance at select conferences. 

Physical Requirements

• Sustained periods of time standing and sitting in a laboratory  
• Sitting at a desk utilizing a   computer  
• Some lifting of <25 pounds  

Working Environment: 

Typical office areas with   offices, cubicles and conference rooms. Typical laboratory and   chemical storage areas which may contain hazardous compounds   requiring adherence to safe handling practices.  

The information contained in this job   description is for compliance with the Americans with Disabilities Act (ADA)   and is not an exhaustive list of duties performed for this position.